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临床试验/NCT03728907
NCT03728907撤回不适用

A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification

San Diego State University0 个研究点开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Real-ear aided output

研究概览

简要总结

Fifty adults with mild to moderately severe sensorineural hearing loss will be fit with hearing amplification using two adjustment techniques. For the "audiologist fitting" technique, a licensed audiologist will adjust the hearing device using the standard of care procedures which include adjustment and verification of output to match prescribed targets (NAL-NL2) and subsequent fine tuning to optimize adjustments based on participant feedback. The second technique is "user-adjustment" of the device consisting of adjustment to overall level, high-frequency boost, and low-frequency cut by the participant while listening to speech. A cross-over design will be used in which half the participants are initially fit using the audiologist technique and the other half are initially fit using the user self-adjustment technique. Following a seven-day field trial, participants will return to the lab and the aids will be reset use the other technique. Participants will be blinded to the condition. During each seven-day field trial, users will have access to a volume control, Following the end of the two trials, participants will return to the lab for outcome assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Outcomes assessors and participants will not be aware of which hearing setting (audiologist adjusted vs. self-adjusted) they are wearing

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • bilateral hearing loss with a minimum of 40 dB HL thresholds at 2000 Hz
  • English speaking

排除标准

  • Score less than 21 on the MoCa (Montreal Cognitive Assessment)
  • Evidence of conductive or retrocochlear pathology

结局指标

主要结局

Real-ear aided output

时间窗: two weeks

aided output (in dB SPL) measured across frequencies in the ears of the participants

次要结局

  • Computerized Assisted Speech Perception Assessment (CASPA)(two weeks)
  • Device Oriented Scale of Improvement (DOSO)(two weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carol L Mackersie

Professor

San Diego State University

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